國立虎尾科技大學 |

Handbook of medical device regulatory affairs in Asia

Record Type:	Language materials, printed : Monograph/item
Title/Author:	Handbook of medical device regulatory affairs in Asia/ edited by Jack Wong, Raymond K.Y. Tong.
other author:	Wong, Jack.
Published:	Singapore :Pan Stanford Publishing, : c2018.,
Description:	1 online resource (xxxiv, 620 p.) :ill. :
Subject:	Medical instruments and apparatus - Safety regulations - Asia. -
Online resource:	https://www.taylorfrancis.com/books/9780429504396
ISBN:	9780429504396

Handbook of medical device regulatory affairs in Asia
Handbook of medical device regulatory affairs in Asia[electronic resource] /edited by Jack Wong, Raymond K.Y. Tong. - 2nd ed. - Singapore :Pan Stanford Publishing,c2018. - 1 online resource (xxxiv, 620 p.) :ill.

Includes bibliographical references and index.

"Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs."--Provided by publisher.

ISBN: 9780429504396

Standard No.: 10.1201/9780429504396 doiSubjects--Topical Terms:

880601
Medical instruments and apparatus
--Safety regulations--Asia.

LC Class. No.: R856.15 / .H36 2018

Dewey Class. No.: 610.28 / H236

Handbook of medical device regulatory affairs in Asia
LDR:01887cam a2200289 a 4500 001 1108507
006 m o d
007 cr cnu---unuuu
008 231024s2018 si a obf 001 0 eng d
020 $a 9780429504396 $q (electronic bk.)
020 $a 9780429996771 $q (ePDF)
020 $a 9780429996757 $q (Mobi)
020 $z 9789814774314 $q (hbk.)
024 7 $a 10.1201/9780429504396 $2 doi
035 $a 9780429504396
040 $a FlBoTFG $b eng $c FlBoTFG
041 0 $a eng
043 $a a------
050 4 $a R856.15 $b .H36 2018
082 0 4 $a 610.28 $b H236
245 0 0 $a Handbook of medical device regulatory affairs in Asia $h [electronic resource] / $c edited by Jack Wong, Raymond K.Y. Tong.
250 $a 2nd ed.
260 $a Singapore : $b Pan Stanford Publishing, $c c2018.
300 $a 1 online resource (xxxiv, 620 p.) : $b ill.
504 $a Includes bibliographical references and index.
520 $a "Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs."--Provided by publisher.
588 $a Description based on print version record.
650 0 $a Medical instruments and apparatus $x Safety regulations $z Asia. $3 880601
650 0 $a Medical instruments and apparatus $x Standards $v Handbooks, manuals, etc. $3 1419178
700 1 $a Wong, Jack. $3 880599
700 1 $a Tong, Raymond. $3 1419177
856 4 0 $u https://www.taylorfrancis.com/books/9780429504396